Status:
UNKNOWN
A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborating Sponsors:
Fudan University
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Investigators aimed to assess Jia Wei Yang He Formula as a plus therapy in the treatment of persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese Medicine treat...
Detailed Description
Asthma is a common chronic inflammatory respiratory disease, patients showed high airway reactivity, and the clinical manifestations of recurrent wheezing, shortness of breath, chest tightness or coug...
Eligibility Criteria
Inclusion
- Patient diagnosed with chronic persistent asthma
- Annual uncontrollable time ≥ 3 months
- Patients who have given written informed consent
Exclusion
- History of upper upper/lower respiratory infection in the previous 1 months
- History of long-term controller medication use for asthma (oral corticosteroid or intravenous corticosteroids therapy) within the preceding 1 months
- History of antibiotic use in the previous 1 months
- History of life-threatening asthma
- History of chronic lung diseases other than asthma, including but not limited to chronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis, sarcoidosis, pulmonary fibrosis, lung cancer, etc
- History of serious disease of the heart and cerebrovascular disease
- History of severe liver or renal dysfunction or disease
- History of severe disease in the hematopoietic system
- History of immunodeficiency (including, but not limited to, HIV positive detection, or other acquired or congenital immunodeficiency disease, or organ transplant history)
- History of any other condition (such as known drug or alcohol abuse or psychiatric disorder) which, in the opinion of the investigator, may preclude the patient from following and completing the protocol
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- History of allergies to the component of the investigated drugs
- Smoking within the past year
- Contraindication to induced sputum collection method on history or examination
- Any serious medical condition which, in the opinion of the Investigator, would pose a significant risk to the patient or interfere with the interpretation of safety, efficacy, or pharmacodynamic data
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03299322
Start Date
October 1 2017
End Date
December 1 2025
Last Update
May 7 2024
Active Locations (8)
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1
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, China, 200032
2
Fengxian District traditional Chinese medicine hospital
Shanghai, China
3
Jingan district center hospital
Shanghai, China
4
Pudong Hospital
Shanghai, China